MERCURY AMALGAM, DENTAL ZINC

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-25 for MERCURY AMALGAM, DENTAL ZINC manufactured by Unk.

Event Text Entries

[68834968] A dentist in (b)(6) put a crown on top of dental zinc and mercury amalgam and then i started using a cell phone that would heat up my head and jaws. Inflammation occurred in my brain with headaches and panic attacks and hyperthyroidism when inflammation subsided after all off of cell phone for 3 weeks, my whole brain and jaws were metallically burned. Is the product compounded: no, amalgam is. Is the product over-the-counter: no. How was is taken or used: upper left #3 tooth and all the other teeth that had molars, amalgam in them. Date the person first started taking or using the product: 1965 - 1996. Date the person stopped taking or using the product: 2004. The person using the product supposed to treat: tooth fillings. Did the problem stop after the person reduced the dose or stopped taking or using the product: no. Did the problem return if the person started taking or using the product again: didn't restart. Do you still have the product in case we need to evaluate it: yes. Dr. (b)(6), may have notes on it.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5068177
• MDR Report Key: 6364185
• Date Received: 2017-02-25
• Date Added to Maude: 2017-02-28
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: MERCURY AMALGAM, DENTAL ZINC
• Generic Name: MERCURY AMALGAM, DENTAL ZINC
• Product Code: ELY
• Date Received: 2017-02-25
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Other; 4. Required No Informationntervention; 5. Deathisabilit	2017-02-25